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CompletedNCT01642576Updated Jul 29, 2015

Comparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile and Quality of Life in Obese Men

A Phase 4 interventional study of weight loss counselling in Sexual Dysfunction, Endothelial Dysfunction and Quality of Life, sponsored by Changi General Hospital. Completed at 1 site in Singapore. Open to male participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-29.

Sponsored by Changi General Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
Male
01

Study summary

This study aims to compare the effects of 8 months of diet modification, with or without exercise, on weight loss, sexual, urinary and endothelial function, systemic inflammation and quality of life in obese men.

02

Conditions studied

  • Sexual Dysfunction
  • Endothelial Dysfunction
  • Quality of Life
  • Inflammation

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Keywords

  • obesity
  • men
  • sexual function
  • urinary tract symptoms
  • endothelial function
  • inflammation
  • quality of life
03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 90 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

Changi General Hospital is the lead sponsor of 98 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male, aged 30-65 years
  • Body Mass Index (BMI) >/= 27.5 kg/m2
  • Waist circumference (WC) >/= 90 cm

Exclusion criteria

Exclusion Criteria:

  • pituitary disease or cranial radiotherapy
  • previous or current androgen replacement or deprivation therapy
  • current treatment for sexual problems or LUTS
  • glomerular filtration rate \< 60 ml/min
  • liver disease
  • alcohol intake exceeding 500 g/week in the previous 12 months
  • use of opiates, glucocorticoids, recreational drugs or phosphodiesterase inhibitors
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    diet modification

    counselling on caloric restriction and healthy eating

    Behavioral: weight loss counselling

  • Experimental
    weight management program

    dietician and sports trainer, physician counselling on weight loss

    Behavioral: weight loss counselling

Interventions

  • Behavioralweight loss counselling

    Diet counselling with or without sports trainers, over 8 months

06

What researchers measure

Primary outcomes

  1. erectile function

    IIEF-5 score

    Time frame: 8 months

Secondary outcomes

  1. lower urinary tract symptoms

    IPSS score

    Time frame: 8 months

07

Study locations

1 site
  • Changi General Hospital
    Singapore, 529889, Singapore
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01642576
Lead sponsor
Changi General Hospital
Responsible party
Sponsor
First posted
Jul 17, 2012
Start date
Jul 2010
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Jul 29, 2015

Study contacts

Joan Khoo, MRCP
principal investigator · Changi General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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